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510(k) K182542

The EPAD 2 System by Safeop Surgical, Inc. — Product Code GWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 2019
Date Received
September 17, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Electrical, Evoked Response
Device Class
Class II
Regulation Number
882.1870
Review Panel
NE
Submission Type

Other clearances by Safeop Surgical, Inc.

  • K132616 — EPAD (January 24, 2014)

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